Upon reassessment of the reported event, it was determined that this event was filed under the incorrect catalog number, bopt6511.(see mfr number 0001038806-2021-00358).A retraction will be submitted for mfr number 0001038806-2021-00358.Catalog number bopt6511 is added as a concomitant device on this report.Zimmer biomet complaint number (b)(4).Weight unknown / not provided.Lot number unknown / not provided.Concomitant medical products: bopt6511, 3i t3¿ tapered implant 6/5 x 11.5mm, lot number: 2019052375.Pma/510(k) number not available.One 3i t3¿ tapered implant 6/5 x 11.5mm (bopt6511) was returned for investigation.However, one internal connection universal placement driver tip long (iipdtul) was not returned.Visual evaluation of the as returned product identified damaged hex and platform being worn out.Implant external threads were somewhat damaged as well, likely from the retrieval process.Dhr review could not be performed for the driver tip (iipdtul) as the lot number was unknown.A year-long complaint history review was performed by items (iipdtul) using keyword category functional: damaged drive feature and no other complaints about nonconforming products were identified.May post market trending was reviewed and there were no actionable events or corrective actions for the reported event (damaged drive feature) or product (iipdtul).Therefore, based on the available information, device malfunction for driver tip could not be verified without the product return.A definitive root cause could not be identified.However, based on the investigation, risk file review and ifu, the most likely cause determined from the investigation are clinician failure to follow recommended protocol for implant placement and final seating or application of excessive torque.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.
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It was reported that while placing an implant at tooth location #18 under torque @50 ncm w / hand piece, the surgeon describes loss of engagement.The surgeon stopped the procedure and found that the driver had stripped the hex of implant.The surgeon removed the implant with a removal kit and used another implant to complete the procedure.As a result of this event, no delays or injury to the patient was reported.
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